The scientific evidence for clinical effectiveness of transcutaneous electrical nerve stimulation (TENS) for treatment of acute, chronic, and labor and delivery pain is assessed in this paper, and it is concluded that there is little evidence for other than a limited use of TENS. The utilization of TENS in Canadian hospitals and payments for TENS services are addressed. Some practicalities regarding the use and assessment of health technologies are discussed.

Objectives: Publication bias is widely appreciated, but considerable time and effort are needed to locate and obtain data from unpublished randomized controlled trials (RCTs), those published in non-English language journals or those reported in the gray literature; for this publication, we will call this collection of trials the “gray+ literature.” However, excluding such trials from systematic reviews could introduce bias and give rise to misleading conclusions.

Methods: We aimed to explore and quantify the impact of inclusion of gray+ literature on the results of all completed individual patient data (IPD) reviews coordinated by our group (13 meta-analyses). For each IPD review, results were calculated for RCTs fully published in English language journals and RCTs fully published in English language journals and the gray+ literature.

Results: The IPD meta-analyses based only on RCTs that were fully published in English language journals tended to give more favorable results than those that included RCTs from the gray+ literature. Although in most cases the addition of gray+ data gave less encouraging results, moving the estimated treatment effect toward a null result, the direction of effect was not always predictable.

Conclusions: We recommend that all systematic reviews should at least attempt to identify trials reported in the gray+thinsp;literature and, where possible, obtain data from them.

Objectives: The aim of this study was to review and compare current health technology assessment (HTA) activities for medical devices across non-European Union HTA agencies.

Methods: HTA activities for medical devices were evaluated from three perspectives: organizational structure, processes, and methods. Agencies were primarily selected upon membership of existing HTA networks. The data collection was performed in two stages: stage 1–agency Web-site assessment using a standardized questionnaire, followed by review and validation of the collected data by a representative of the agency; and stage 2–semi-structured telephone interviews with key informants of a sub-sample of agencies.

Results: In total, thirty-six HTA agencies across twenty non-EU countries assessing medical devices were included. Twenty-seven of thirty-six (75 percent) agencies were judged at stage 1 to have adopted HTA-specific approaches for medical devices (MD-specific agencies) that were largely organizational or procedural. There appeared to be few differences in the organization, process and methods between MD-specific and non–MD-specific agencies. Although the majority (69 percent) of both categories of agency had specific methods guidance or policy for evidence submission, only one MD-specific agency had developed methodological guidelines specific to medical devices. In stage 2, many MD-specific agencies cited insufficient resources (budget, skilled employees), lack of coordination (between regulator and reimbursement bodies), and the inability to generalize findings from evidence synthesis to be key challenges in the HTA of medical devices.

Conclusions: The lack of evidence for differentiation in scientific methods for HTA of devices raises the question of whether HTA needs to develop new methods for medical devices but rather adapt existing methodological approaches. In contrast, organizational and/or procedural adaptation of existing HTA agency frameworks to accommodate medical devices appear relatively commonplace.

Objectives: Multidisciplinary and multifactorial interventions seem to be effective in preventing falls. We aimed to assess the cost-effectiveness of a multidisciplinary fall prevention program compared with usual Dutch healthcare in community-dwelling people 65 years of age or older who experienced a fall.

Methods: Cost-effectiveness and cost-utility analysis were performed from a societal perspective. Falls and healthcare utilization were continuously measured for 12 months. Daily functioning and quality of life were measured at baseline, after 4 and 12 months. Bootstrap analyses were performed to estimate uncertainty of the findings and sensitivity analysis to assess the generalizability of assumptions made.

Results: One hundred sixty-six participants were randomly allocated to the experimental group and 167 to the control group. The overall response rate was 74 percent. Healthcare and patient and family costs of both groups were comparable. Our analyses showed no effect of the intervention program on falls, daily functioning, or quality of life measures.

Conclusions: The multidisciplinary intervention program to prevent falls was not cost-effective compared with usual care in the Netherlands. Notwithstanding our findings, however, falls still have an important impact on society and individuals in terms of costs and effects. Economic evaluations studying promising interventions to prevent falls, therefore, remain necessary.

Objectives: The aim of this study is to explain factors influential to the diffusion of computed tomography (CTs) and magnetic resonance imaging (MRIs).

Methods: Variables were identified from a review of the literature on the diffusion of health technologies. A formal process was applied to build a conceptual model of the mechanism that drives technology diffusion. Variables for the analysis were classified as predisposing, enabling, or reinforcing factors, in keeping with a model commonly used to explain the diffusion of health behaviors. Multiple regression analysis was conducted using year 2000 OECD data.

Results: The results of this study showed that total health expenditure per capita (p < .01, both CTs and MRIs) and flexible payment methods to hospitals (p < .05, both CTs and MRIs) were significantly associated with the diffusion of CTs and MRIs (adjusted R2 = 0.477, 0.656, respectively).

Conclusions: This study presents a systematically developed model of the mechanism governing technology diffusion. Important findings from the study show that purchasing power, represented by total health expenditure per capita and economic incentives to hospitals in the form of flexible payment methods, were positively correlated with diffusion. Another important achievement of our model is that it accounts for all thirty OECD member countries without excluding any as outliers. This study shows that variation across countries in the diffusion of medical technology can be explained well by a logical model with multiple variables, the results of which hold profound implications for health policy regarding the adoption of innovations.

Objectives: The complexity of health technology assessment (HTA) has increased, in part because of its evolution through three distinct phases: the machine, the clinical outcomes, and the delivery models. However, the theoretical foundation for the field remains underdeveloped.

Methods: It is high time for HTA to bring together aspects of conceptual and theoretical works from other fields to strengthen the foundation of HTA.

Results: Many challenges await the further development of HTA. They can be captured around three research themes: adapting HTA to an evolving analysis object; translating HTA results into policy, management, and practice decisions; and evaluating organizational models of HTA.

Conclusions: Consolidating the scientific basis of HTA is essential if we are to succeed in increasing the relevance of HTA in some of the most challenging health-related decisions that we will make as individuals and societies.

Objectives: Infliximab is a costly therapy for active Crohn's disease resistant to corticosteroids and immunosuppressive medication. The purpose of this study was to examine whether a treatment including infliximab (episodic re-infusions for relapse or maintenance therapy every 8 weeks) was relevant compared with conventional management (surgery and medical treatment without infliximab) for nonfistulizing resistant Crohn's disease.

Methods: We performed a life-time cost-utility analysis with an analytic Markov decision model from the perspective of the third-party payer system. Utility measurement using Standard Gamble was used to adjust the survival time for each health state of the disease. Direct costs were estimated from standard management based on expert opinion. A sensitivity analysis was conducted to gauge the effects of uncertainty in the values assigned to variables.

Results: The incremental effectiveness with infliximab therapy is .761 Quality-Adjusted Life Years (QALYs) for an added cost ranging from 48,478.79 euros to 596,990.35 euros, depending on treatment procedure. The incremental cost utility ratio expressed in euros per QALYs saved varied from 63,700.82 euros (episodic re-infusions) to over 762,245.09 euros (maintenance therapy).

Conclusions: Infliximab therapy could be cost-effective in the case of relapse treatment only, whereas the marginal cost-utility ratio exceeds conventional benchmarks for maintenance therapy. This analysis will be supplemented by conducting further randomized controlled trials and prospective observational study, focused on the costs of illness (direct and indirect), patient preferences, the disease's clinical course, and infliximab safety.

The aim of this paper is to discuss the use of Bayesian methods in cost-effectiveness analysis (CEA) and the common ground between Bayesian and traditional frequentist approaches. A further aim is to explore the use of the net benefit statistic and its advantages over the incremental cost-effectiveness ratio (ICER) statistic. In particular, the use of cost-effectiveness acceptability curves is examined as a device for presenting the implications of uncertainty in a CEA to decision makers. Although it is argued that the interpretation of such curves as the probability that an intervention is cost-effective given the data requires a Bayesian approach, this should generate no misgivings for the frequentist. Furthermore, cost-effectiveness acceptability curves estimated using the net benefit statistic are exactly equivalent to those estimated from an appropriate analysis of ICERs on the cost-effectiveness plane. The principles examined in this paper are illustrated by application to the cost-effectiveness of blood pressure control in the U.K. Prospective Diabetes Study (UKPDS 40). Due to a lack of good-quality prior information on the cost and effectiveness of blood pressure control in diabetes, a Bayesian analysis assuming an uninformative prior is argued to be most appropriate. This generates exactly the same cost-effectiveness results as a standard frequentist analysis.

Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are among the most prestigious health care technologies. Their popularity has grown rapidly, and an increasing proportion of health care resources is allocated to them. We studied patient- and hospital-related factors that cause variation in a major determinant of hospital costs, the length of hospital stay (LOS) for THA and TKA. We gathered data on 10,288 hip and 5,173 knee patients with primary or secondary arthrosis from the Finnish Arthroplasty Register, which we linked with the Finnish Hospital Discharge Register. Patientand hospital-related variations in LOS were explained using regression models. Of the patient-related factors, complications caused the greatest prolongation of hospital stay, but patient's age, gender, and charge category also influenced LOS. Hospital-related factors were major causes of LOS variation. In the hospitals the average case-mix-adjusted LOS ranged from less than a week to 3 weeks. The number of arthroplasties performed in hospital was inversely related to LOS. The within-hospital LOS figures for THA and TKA were strikingly similar and persistent.

Objectives: The aim of this study was to adapt and assess the value of a Multi-Criteria Decision Analysis (MCDA) framework (EVIDEM) for the evaluation of Orphan drugs in Catalonia (Catalan Health Service).

Methods: The standard evaluation and decision-making procedures of CatSalut were compared with the EVIDEM methodology and contents. The EVIDEM framework was adapted to the Catalan context, focusing on the evaluation of Orphan drugs (PASFTAC program), during a Workshop with sixteen PASFTAC members. The criteria weighting was done using two different techniques (nonhierarchical and hierarchical). Reliability was assessed by re-test.

Results: The EVIDEM framework and methodology was found useful and feasible for Orphan drugs evaluation and decision making in Catalonia. All the criteria considered for the development of the CatSalut Technical Reports and decision making were considered in the framework. Nevertheless, the framework could improve the reporting of some of these criteria (i.e., “unmet needs” or “nonmedical costs”). Some Contextual criteria were removed (i.e., “Mandate and scope of healthcare system”, “Environmental impact”) or adapted (“population priorities and access”) for CatSalut purposes. Independently of the weighting technique considered, the most important evaluation criteria identified for orphan drugs were: “disease severity”, “unmet needs” and “comparative effectiveness”, while the “size of the population” had the lowest relevance for decision making. Test–retest analysis showed weight consistency among techniques, supporting reliability overtime.

Conclusions: MCDA (EVIDEM framework) could be a useful tool to complement the current evaluation methods of CatSalut, contributing to standardization and pragmatism, providing a method to tackle ethical dilemmas and facilitating discussions related to decision making.

Eighty-one published papers on the performance of prostheses in total hip replacement were appraised. Sound methodology was demonstrated in 1 of 8 randomized controlled trials and 4 of 17 nonrandomized comparative studies. Of 56 case series without controls, 32 met the appraisal criteria, but these are intrinsically less useful. The published literature does not provide solid evidence for the superiority of cement-free or hybrid prostheses over modern cemented types.

Objectives: In the United States, medical devices represent an eighty-billion dollar a year market. The U.S. Food and Drug Administration rejects a significant number of applications of devices that reach the investigational stage. The prospects of improving patient condition, as well as firms' profits, are thus substantial, but fraught with uncertainties at the time when investments and design decisions are made. This study presents a quantitative model focused on the risk aspects of early technology assessment, designed to support the decisions of medical device firms in the investment and development stages.

Methods: The model is based on the engineering risk analysis method involving systems analysis and probability. It assumes use of all evidence available (both direct and indirect) and integrates the information through a linear formula of aggregation of probability distributions. The model is illustrated by a schematic version of the case of the AtrialShaper, a device for the reduction of stroke risk that is currently in the preprototype stage.

Results: The results of the modeling provide a more complete description of the evidence base available to support early-stage decisions, thus allowing comparison of alternative designs and management alternatives.

Conclusions: The model presented here provides early-stage decision-support to industry, but also benefits regulators and payers in their later assessment of new devices and associated procedures.

Objectives: The aim of this study was to provide a comprehensive summary and interpretation of the current evidence on the use and validity of statistical methods to conduct indirect comparisons of treatment effects.

Methods: A narrative review was conducted.

Results: Well-conducted methodological studies provide good evidence that adjusted indirect comparisons can lead to results similar to those from direct comparisons. The internal validity of several statistical methods to conduct indirect comparisons, therefore, has been established. Meta-regression, logistic regression, or adjusted indirect comparisons should be the methods of first choice. Unadjusted indirect comparisons are always unacceptable. Deciding whether to combine direct and indirect evidence will be a matter of informed judgment based on the similarities and dissimilarities of populations and interventions. Unverifiable assumptions with respect to the similarity of compared studies and low power are serious limitations of indirect comparisons.

Conclusions: In the absence of sufficient head-to-head evidence, adjusted indirect comparisons can be viewed as additional analytical tools to determine the comparative efficacy and effectiveness of competing interventions. Researchers who use indirect comparisons need to keep the limitations in mind.

In this study, we describe the current state of the Health Technology Assessment (HTA) system in England and Wales. This system rests on a distinction between assessment and appraisal and has three main strands: researcher-led HTA, the research and development program, and the HTA-NICE (National Institute for Clinical Excellence) process. We outline the pressures for HTA and how it has evolved in the British National Health Service. We discuss how HTA priorities are chosen, how HTA information is collected and assessed, how HTA evidence is used, and we make some observations about its impact. In our discussion, we consider some limitations of the HTA system, its possible divergence from evidence-based health care, its centralization, and some of the key challenges for managing HTA-driven policy. But we remain hopeful that HTA can contribute to better and more explicit decision-making within England and Wales.

Objectives: Registers have proven to be a valuable instrument in the evaluation of arthroplasty procedures and the performance of implants. The aim of this study was to describe the structure, functioning, and content of arthroplasty registers in Europe and other parts of the world.

Methods: A search of technical reports was carried out through the Internet and in Medline/PubMed. The exhaustiveness of the information was confirmed using the links to Web pages of other registers and contacts with key people. Aims, methods in data collection and evaluation, internal structure and organization, participants, validity of the data, and other variables were assessed for each arthroplasty register using a qualitative content analysis of the texts.

Results: Fifteen arthroplasty registers were identified which published sufficient information to conduct a comparative analysis. Eight additional registers were identified but no information was available on the Internet or in English. Most registers were initiatives of an orthopaedic society receiving governmental funding. Data were collected using standardized clinical forms and additional information from clinical-administrative datasets or other registers (mortality, implant costs, hip fractures). The main outcome measure of these registers is survival of the prostheses. Registers use the Internet and their annual reports as the main strategy for the dissemination and feed-back of their results.

Conclusions: Scientific or professional societies and the public health administration should collaborate in the development of arthroplasty registers. To adequately assess the results of observational data information on the structure, the process of arthroplasty interventions and patients characteristics should be collected.

The development and diffusion of health-related technologies constitute an extremely complex process. This article examines the phenomenon of technological innovation; discusses the factors determining the diffusion of high, medium, and low technologies; and suggests strategies for controlling the diffusion of these technologies. A research program is also proposed that should improve our understanding of the process of development and diffusion of health-related technologies.

Objectives: The objectives of this study were (i) to develop a systematic framework for describing and comparing different features of health technology assessment (HTA) agencies, (ii) to identify and describe similarities and differences between the agencies, and (iii) to draw conclusions both for producers and users of HTA in research, policy, and practice.

Methods: We performed a systematic literature search, added information from HTA agencies, and developed a conceptual framework comprising eight main domains: organization, scope, processes, methods, dissemination, decision, implementation, and impact. We grouped relevant items of these domains in an evidence table and chose five HTA agencies to test our framework: DAHTA@DIMDI, HAS, IQWiG, NICE, and SBU. Item and domain similarity was assessed using the percentage of identical characteristics in pairwise comparisons across agencies. Results were interpreted across agencies by demonstrating similarities and differences.

Results: Based on 306 included documents, we identified 90 characteristics of eight main domains appropriate for our framework. After applying the framework to the five agencies, we were able to show 40 percent similarities in “dissemination,” 38 percent in “scope,” 35 percent in “organization,” 29 percent in “methods,” 26 percent in “processes,” 23 percent in “impact,” 19 percent in “decision,” and 17 percent in “implementation.”

Conclusion: We found considerably more differences than similarities of HTA features across agencies and countries. Our framework and comparison provides insights and clarification into the need for harmonization. Our findings could serve as descriptive database facilitating communication between producers and users.

Objectives: This study aims to describe a cycle of development leading to sustainable methods for involving consumers in the management of a program commissioning health technology assessment.

Methods: Staff time was dedicated to developing procedures for recruiting and briefing consumers to participate in prioritizing, commissioning, and reporting research. Resources and support were developed in light of early feedback from consumers and those working with them. These were piloted and amended before being used routinely.

Results: Over 4 years, procedures and resources have been developed to support six consumers attending seven to eight prioritization meetings a year; thirty to forty-five consumers each year commenting on research need for particular topics; thirty consumers a year commenting on research proposals, and twenty a year commenting on research reports. The procedures include clear job descriptions, induction and development days, clear briefing materials, payment for substantial tasks, and regularly seeking feedback to improve procedures.

Conclusions: Explicit, inclusive, and reproducible methods for supporting consumer involvement that satisfy National Health Service policy recommendations for involving consumers in research require dedicated staff time to support a cycle of organizational development.